The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Angiographic Catheter.
Device ID | K926243 |
510k Number | K926243 |
Device Name: | ANGIOGRAPHIC CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
Contact | Grace Carland |
Correspondent | Grace Carland TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-11 |
Decision Date | 1993-08-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613252187035 | K926243 | 000 |
07613252186977 | K926243 | 000 |
04546540688071 | K926243 | 000 |
04546540688064 | K926243 | 000 |
04546540688040 | K926243 | 000 |
04546540688033 | K926243 | 000 |